Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. Marketing Category What is the Marketing Category? For unapproved drugs, this field will be null. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. Name of Company corresponding to the labeler code segment of the Product NDC.įDA Application Number What is the FDA Application Number? Product Labeler Information What is the Labeler Name? The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
0 Comments
Leave a Reply. |
Details
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |